Vinpocetine Inhibits NF-κB-dependent Inflammation in Acute Ischemic Stroke Patients

Phase 2

Completed

• Conditions: Inflammation; Vinpocetine; Stroke; Immunoregulation
• Interventions: Drug: Aspirin; Drug: vinpocetine

• Registration Number: NCT02878772
• Lead Sponsor: Tianjin Medical University General Hospital

Brief Summary

Immunity and inflammation play critical roles in the pathogenesis of acute ischemic stroke. Therefore, immune intervention, as a new therapeutic strategy, is worthy of exploration. Here, investigators tested the inflammation modulator, vinpocetine, for its effect on the outcomes of stroke. For this multi-center study, investigators recruited 60 patients with anterior cerebral circulation occlusion and onset of stroke that had exceeded 4.5 hours but lasted less than 48 hours. These patients, after randomly division into two groups, received either standard management alone (controls) or standard management plus vinpocetine (30 mg per day intravenously for 14 consecutive days, Gedeon Richter Plc., Hungary).

Detailed Description

Not available

Study Timeline

• Study Start: 2014-05
• Primary Completion: 2015-12
• Study Completion: 2015-12
• Status Verified: 2016-08
• Study First Submitted: 2016-08-04
• Study First Submitted QC: 2016-08-24
• Last Update Submitted: 2016-08-24
• Study First Posted: 2016-08-25
• Last Update Posted: 2016-08-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• >18 years of age
• Anterior-circulation ischemic stroke: All patients had symptoms of focal neurological deficits and simultaneous radiological evidence (magnetic resonance imaging, MRI) of an ischemic brain lesion
• measurable neurological deficit (NIHSS > 5)
• interval between symptom onset and admission more than 4.5 hours and less than 48 hours. That is, all patients we recruited were beyond the 4.5 hours of symptom onset and, therefore, past the accepted time-window for thrombolytic therapy

Exclusion Criteria

• hemorrhagic stroke and severe hemorrhage in other organs
• other diseases of the central nervous system (CNS)
• diabetes mellitus
• tumor or hematological systemic diseases
• any infection before acute ischemic stroke
• concomitant use of antineoplastic or immune modulating therapies
• contraindication to MRI

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Aspirin	Patients will receive aspirin only.
vinpocetine group	Aspirin	Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days
vinpocetine group	vinpocetine	Aspirin, 10mg, po and 30 mg of the vinpocetine by intravenous infusion once daily, for fourteen consecutive days

Primary Outcome Measures

Name	Time	Method
changes in lesion volume	lesion volume from baseline to day 7	changes in lesion volume from baseline (DWI) to day 7 (Flair)
extent of clinical improvement	from baseline to day 7 and 14	extent of clinical improvement at day 7 and 14, as measured by the changes on the NIHSS score from baseline to day 7 and 14
brain inflammatory level	day 7	brain inflammatory level (MRS) at day 7

Secondary Outcome Measures

Name	Time	Method
cytotoxic edema	day 3	cytotoxic edema of day 3 (ADC value).
probability of excellent recovery	at day 90	probability of excellent recovery at day 90 (defined as a score of 0 or 1 on the mRS)